Identity
- Trade Name
- PURIST Leg Positioning System EUDAMED
- Device Name
- PURIST Leg Positioning System EUDAMED
- Model / Reference
- 6813100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701602300105 EUDAMED
- Basic UDI-DI
- 037016023DT008PURISTAK EUDAMED
- Direct Marketing DI
- 03701602300105 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PURIST Leg Positioning System by Innovative Orthopedic Technologies IOT AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: The Purist Measurable, reproducible positioning for anterior hip replacement.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 037016023DT008PURISTAK | Class I | Active |
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Manufacturer
- Manufacturer
- Innovative Orthopedic Technologies IOT AG
- EUDAMED SRN
- CH-MF-000041418
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED 31b8608c-7e50-42fd-95d7-d43431b98e31 61 fields · synced Jun 18, 2026